Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)

Acute Diverticulitis Clinical Trial

— STELLA  

Official title:

Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008707
• Other study ID #: n° 890
• Status: Completed
• Start date: November 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD

Description:

In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute abdominal pain,

• Signs of localized or diffuse peritonitis

• Signs of suspected perforated diverticulitis (diagnostic imaging)

• Signed informed consent

Exclusion Criteria:

• Septic shock

• Immunodepression

• Previous multiple abdominal surgical operations

• Modified Hinchey's grade IV

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Intervention

Procedure:
• Laparoscopic Peritoneal Lavage
LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero, Universitaria Pisana	Pisa	Tuscany

Sponsors (8)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana	A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, George Papanicolaou Hospital, Hospitales Universitarios Virgen del Rocío, Maggiore Bellaria Hospital, Bologna, Ospedale San Jacopo, Pistoia, S. Andrea Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term Morbidity		30 days
Primary	Short-term Mortality		30 days
Primary	Optimal Sepsis Control		30 days
Primary	Post-operative Re-interventions Rate		15 days
Secondary	Mean Postoperative Time		1 day
Secondary	Average Length of Postoperative Hospital Stay		30 day
Secondary	Recurrent Colonic Diverticulitis Rate		6 months
Secondary	Incisional Hernia Rate		6 months